Barden are delighted to be supporting our renowned biotechnology client that specializes in the research, development, and commercialization of innovative therapies in the field of life sciences in their search for a Senior Manager Clinical Quality & Compliance. Our client is widely recognized for its ground-breaking contributions to the treatment of infectious diseases.
ABOUT THE ROLE:
- Represent R&D Quality & Medical Governance on the global clinical study management teams advising on areas of GCP risk.
- Serve as Clinical Quality Business Partner lead for assigned clinical trial programs.
- Act as Subject Matter Expert performing global risk assessment for investigator site and vendor audit planning.
- Collaborate with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance.
- Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- Lead or Assist in readiness preparation, and/or directly support regulatory agency inspection.
- Lead deviation identification, reporting, and CAPA development.
- Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
ABOUT THE PERSON:
- BA or BS and 5+ years of relevant experience
- Strong GCP audit and compliance experience. Bio-pharma sponsor experience preferred.
- Recognized as an expert resource on a range of clinical compliance topics.
Please get in touch with Aidan Crowley in Barden (email@example.com) to discuss further.